Left Ventricular Assist Device Combined With Allogeneic Mesenchymal Stem Cells Implantation in Patients With End-stage Heart Failure.

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by AHEPA University Hospital
Sponsor:
Information provided by (Responsible Party):
Kyriakos Anastasiadis, AHEPA University Hospital
ClinicalTrials.gov Identifier:
NCT01759212
First received: December 18, 2012
Last updated: November 27, 2013
Last verified: November 2013
  Purpose

The aim of the study is to investigate safety and efficacy of intramyocardial implantation of allogeneic mesenchymal stem cells in patients with end-stage ischemic cardiomyopathy undergoing left ventricular assist device implantation.


Condition Intervention Phase
Heart Failure
Ischemic Cardiomyopathy
Biological: Allogeneic stem cells implantation
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Intramyocardial Implantation of Allogeneic Mesenchymal Stem Cells in Patients With End-stage Heart Failure Undergoing Left Ventricular Assist Device Implantation

Resource links provided by NLM:


Further study details as provided by AHEPA University Hospital:

Primary Outcome Measures:
  • Improvement in myocardial perfusion/viability [ Time Frame: one year ] [ Designated as safety issue: No ]
    Improvement in myocardial perfusion/viability assessed with SPECT segmental analysis


Secondary Outcome Measures:
  • all-cause morbidity [ Time Frame: one year ] [ Designated as safety issue: No ]
  • left ventricular function [ Time Frame: one year ] [ Designated as safety issue: No ]
    Change in left ventricular function after combined mechanical and cellular therapy

  • all-cause mortality [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 5
Study Start Date: October 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stem cells implantation
Patients with end-stage heart failure due to ischemic cardiomyopathy will undergo combined cellular and mechanical support with implantation of off-the-shelf allogeneic mesenchymal stem cells and left ventricular assist device.
Biological: Allogeneic stem cells implantation

Detailed Description:

End-stage ischemic cardiomyopathy (ICM) with non-graftable coronary arteries is a common and debilitating problem. The ultimate therapeutic goal in such cases is cardiac transplantation which is restricted by donor availability. Alternatively, left ventricular assist devices (LVAD) are increasingly used as bridge to transplantation or more recently as destination therapy in non-transplant candidates. Widely used second- and third-generation continuous-flow LVAD offer symptomatic relief and prolong life. However, LV unloading rarely improves native heart function in ischemic hearts. We aim to increase myocardial viability and improve native cardiac function in patients with end-stage ICM by injecting allogeneic bone marrow stem cells at the time of LVAD implantation.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 to 75 years
  • End-stage heart failure due to ischemic cardiomyopathy that requires mechanical support according to current indications
  • Ability to provide informed consent

Exclusion Criteria:

  • Not willing to provide informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01759212

Contacts
Contact: Polychronis Antonitsis, MD, DSc +30 2310 994871 antonits@auth.gr

Locations
Greece
AHEPA University Hospital Recruiting
Thessaloniki, Greece, 546 36
Contact: Polychronis Antonitsis, MD, DSc    +30 2310 994871    antonits@auth.gr   
Principal Investigator: Kyriakos Anastasiadis, MD, DSc, FETCS         
Sub-Investigator: Polychronis Antonitsis, MD, DSc         
Sponsors and Collaborators
AHEPA University Hospital
Investigators
Principal Investigator: Kyriakos Anastasiadis, MD, DSc, FETCS AHEPA University Hospital
  More Information

Publications:
Responsible Party: Kyriakos Anastasiadis, Associate Professor Kyriakos Anastasiadis, AHEPA University Hospital
ClinicalTrials.gov Identifier: NCT01759212     History of Changes
Other Study ID Numbers: AHEPA_CTL_02
Study First Received: December 18, 2012
Last Updated: November 27, 2013
Health Authority: Greece: Ethics Committee

Keywords provided by AHEPA University Hospital:
stem cell implantation
coronary artery disease
left ventricular assist device

Additional relevant MeSH terms:
Heart Failure
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 29, 2014